Cefpodoxime Proxetil
Cefpodoxime Proxetil Prescribing Information
Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
DOSAGE AND ADMINISTRATIONCefpodoxime proxetil tablets should be administered orally with food to enhance absorption. (See
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Acute bacterial exacerbations of chronic bronchitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Acute otitis media | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 h (Max 200 mg/dose) | 5 days |
| Pharyngitis and/or tonsillitis | 10 mg/kg/day (Max 200 mg/day) | 5 mg/kg/dose Q 12 h (Max 100 mg/dose) | 5 to 10 days |
| Acute maxillary sinusitis | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 hours (Max 200 mg/dose) | 10 days |
For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.
Males:
(mL/min) 72 x serum creatinine (mg/100 mL)
Females: 0.85 x above value
(mL/min)
DOSAGE AND ADMINISTRATIONCefpodoxime proxetil tablets should be administered orally with food to enhance absorption. (See
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Acute bacterial exacerbations of chronic bronchitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Acute otitis media | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 h (Max 200 mg/dose) | 5 days |
| Pharyngitis and/or tonsillitis | 10 mg/kg/day (Max 200 mg/day) | 5 mg/kg/dose Q 12 h (Max 100 mg/dose) | 5 to 10 days |
| Acute maxillary sinusitis | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 hours (Max 200 mg/dose) | 10 days |
For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.
Males:
(mL/min) 72 x serum creatinine (mg/100 mL)
Females: 0.85 x above value
(mL/min)
CLINICAL TRIALSIn two double-blind, 2:1 randomized, comparative trials performed in adults in the United States, cefpodoxime proxetil was compared to other beta-lactam antibiotics. In these studies, the following bacterial eradication rates were obtained at 5 to 9 days after therapy:
Pathogen | Cefpodoxime | Comparator |
E. coli | 200/243 (82%) | 99/123 (80%) |
| Other pathogens | 34/42 (81%) | 23/28 (82%) |
K. pneumoniae P. mirabilis S. saprophyticus | ||
| TOTAL | 234/285 (82%) | 122/151 (81%) |
In these studies, clinical cure rates and bacterial eradication rates for cefpodoxime proxetil were comparable to the comparator agents; however, the clinical cure rates and bacteriologic eradication rates were lower than those observed with some other classes of approved agents for cystitis.
Acute Otitis Media Studies
In controlled studies of acute otitis media performed in the United States, where significant rates of beta-lactamase-producing organisms were found, cefpodoxime proxetil was compared to cefixime. In these studies, using very strict evaluability criteria and microbiologic and clinical response criteria at the 4 to 21 day post-therapy follow-up, the following presumptive bacterial eradication/clinical success outcomes (cured and improved) were obtained.
| Cefpodoxime Proxetil | Cefixime | |
Pathogen | 5 mg/kg Q 12 h x 5 d | |
S. pneumoniae | 88/122 (72%) | 72/124 (58%) |
H. influenzae | 50/76 (66%) | 61/81 (75%) |
M. catarrhalis | 22/39 (56%) | 23/41 (56%) |
S. pyogenes | 20/25 (80%) | 13/23 (57%) |
| Clinical success rate | 171/254 (67%) | 165/258 (64%) |
Manufactured for:
East Brunswick, NJ 08816
USA
Made in India
Code: TS/DRUGS/78/1996
Revised: 09/2023
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil and other antibacterial drugs, cefpodoxime proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGECefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime. Therapy may be instituted while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefpodoxime proxetil and other antibacterial drugs, cefpodoxime proxetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefpodoxime proxetil tablets should be administered orally with food to enhance absorption. (See
CLINICAL PHARMACOLOGYCefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime. Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically. Over the recommended dosing range (100 to 400 mg), approximately 29 to 33% of the administered cefpodoxime dose was excreted unchanged in the urine in 12 hours. There is minimal metabolism of cefpodoxime
Effects of Food:
The extent of absorption (mean AUC) and the mean peak plasma concentration increased when film-coated tablets were administered with food. Following a 200 mg tablet dose taken with food, the AUC was 21 to 33% higher than under fasting conditions, and the peak plasma concentration averaged 3.1 mcg/mL in fed subjects versus 2.6 mcg/mL in fasted subjects. Time to peak concentration was not significantly different between fed and fasted subjects.
When a 200 mg dose of the suspension was taken with food, the extent of absorption (mean AUC) and mean peak plasma concentration in fed subjects were not significantly different from fasted subjects, but the rate of absorption was slower with food (48% increase in Tmax).
Pharmacokinetics of Cefpodoxime Proxetil Film-coated Tablets:
Over the recommended dosing range (100 to 400 mg), the rate and extent of cefpodoxime absorption exhibited dose-dependency; dose-normalized Cmaxand AUC decreased by up to 32% with increasing dose. Over the recommended dosing range, the Tmaxwas approximately 2 to 3 hours and the T1/2ranged from 2.09 to 2.84 hours. Mean Cmaxwas 1.4 mcg/mL for the 100 mg dose, 2.3 mcg/mL for the 200 mg dose, and 3.9 mcg/mL for the 400 mg dose. In patients with normal renal function, neither accumulation nor significant changes in other pharmacokinetic parameters were noted following multiple oral doses of up to 400 mg Q 12 hours.
Dose (cefpodoxime equivalents) | Time after oral ingestion | ||||||
1hr | 2hr | 3hr | 4hr | 6hr | 8hr | 12hr | |
| 100 mg | 0.98 | 1.4 | 1.3 | 1 | 0.59 | 0.29 | 0.08 |
| 200 mg | 1.5 | 2.2 | 2.2 | 1.8 | 1.2 | 0.62 | 0.18 |
| 400 mg | 2.2 | 3.7 | 3.8 | 3.3 | 2.3 | 1.3 | 0.38 |
In adult subjects, a 100 mg dose of oral suspension produced an average peak cefpodoxime concentration of approximately 1.5 mcg/mL (range: 1.1 to 2.1 mcg/mL), which is equivalent to that reported following administration of the 100 mg tablet. Time to peak plasma concentration and area under the plasma concentration-time curve (AUC) for the oral suspension were also equivalent to those produced with film-coated tablets in adults following a 100 mg oral dose.
The pharmacokinetics of cefpodoxime were investigated in 29 patients aged 1 to 17 years. Each patient received a single, oral, 5 mg/kg dose of cefpodoxime oral suspension. Plasma and urine samples were collected for 12 hours after dosing. The plasma levels reported from this study are as follows:
| 1Dose did not exceed 200 mg. | |||||||
Dose (cefpodoxime equivalents) | Time after oral ingestion | ||||||
1hr | 2hr | 3hr | 4hr | 6hr | 8hr | 12hr | |
| 5 mg/kg1 | 1.4 | 2.1 | 2.1 | 1.7 | 0.9 | 0.4 | 0.09 |
Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma.
Skin Blister:
Following multiple-dose administration every 12 hours for 5 days of 200 mg or 400 mg cefpodoxime proxetil, the mean maximum cefpodoxime concentration in skin blister fluid averaged 1.6 and 2.8 mcg/mL, respectively. Skin blister fluid cefpodoxime levels at 12 hours after dosing averaged 0.2 and 0.4 mcg/mL for the 200 mg and 400 mg multiple-dose regimens, respectively.
Tonsil Tissue:
Following a single, oral 100 mg cefpodoxime proxetil film-coated tablet, the mean maximum cefpodoxime concentration in tonsil tissue averaged 0.24 mcg/g at 4 hours post-dosing and 0.09 mcg/g at 7 hours post-dosing. Equilibrium was achieved between plasma and tonsil tissue within 4 hours of dosing. No detection of cefpodoxime in tonsillar tissue was reported 12 hours after dosing. These results demonstrated that concentrations of cefpodoxime exceeded the MIC90of
Lung Tissue:
Following a single, oral 200 mg cefpodoxime proxetil film-coated tablet, the mean maximum cefpodoxime concentration in lung tissue averaged 0.63 mcg/g at 3 hours post-dosing, 0.52 mcg/g at 6 hours post-dosing, and 0.19 mcg/g at 12 hours post-dosing. The results of this study indicated that cefpodoxime penetrated into lung tissue and produced sustained drug concentrations for at least 12 hours after dosing at levels that exceeded the MIC90for S. pneumoniae and H. influenzae.
CSF:
Adequate data on CSF levels of cefpodoxime are not available.
Effects of Decreased Renal Function:
Elimination of cefpodoxime is reduced in patients with moderate to severe renal impairment (<50 mL/min creatinine clearance). (See
Effect of Hepatic Impairment (cirrhosis):
Absorption was somewhat diminished and elimination unchanged in patients with cirrhosis. The mean cefpodoxime T1/2and renal clearance in cirrhotic patients were similar to those derived in studies of healthy subjects. Ascites did not appear to affect values in cirrhotic subjects. No dosage adjustment is recommended in this patient population.
Pharmacokinetics in Elderly Subjects:
Elderly subjects do not require dosage adjustments unless they have diminished renal function. (See
Microbiology:
Mechanism of Action:
Cefpodoxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefpodoxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.
Mechanism of Resistance:
Resistance to cefpodoxime is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability.
Cefpodoxime has been shown to be active against most isolates of the following bacteria, both
Gram-positive bacteria:
Staphylococcus aureus
Gram-negative bacteria:
Escherichia coli
The following
Gram-positive bacteria:
Streptococcus agalactiae
Gram-negative bacteria:
Citrobacter diversus
Anaerobic Gram-positive bacteria:
Peptostreptococcus magnus
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Acute bacterial exacerbations of chronic bronchitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Acute otitis media | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 h (Max 200 mg/dose) | 5 days |
| Pharyngitis and/or tonsillitis | 10 mg/kg/day (Max 200 mg/day) | 5 mg/kg/dose Q 12 h (Max 100 mg/dose) | 5 to 10 days |
| Acute maxillary sinusitis | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 hours (Max 200 mg/dose) | 10 days |
For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.
Males:
(mL/min) 72 x serum creatinine (mg/100 mL)
Females: 0.85 x above value
(mL/min)
Cefpodoxime proxetil is contraindicated in patients with a known allergy to cefpodoxime or to the cephalosporin group of antibiotics.
In clinical trials using
Diarrhea 7%
Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had
WARNINGSIf CDAD is suspected or confirmed, ongoing antibiotic use not directed against
A concerted effort to monitor for
In post-marketing experience outside the United States, reports of pseudomembranous colitis associated with the use of cefpodoxime proxetil have been received.
Nausea 3.3%
Vaginal Fungal Infections 1%
Vulvovaginal Infections 1.3%
Abdominal Pain 1.2%
Headache 1%
In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). There were no deaths or permanent disabilities in any of the patients in these studies. Twenty-four patients (1.1%) discontinued medication due to adverse events thought possibly or probably related to study drug. Primarily, these discontinuations were for gastrointestinal disturbances, usually diarrhea, vomiting, or rashes.
Adverse events thought possibly or probably related, or of unknown relationship to cefpodoxime proxetil for oral suspension in multiple-dose clinical trials (N=2128 patients treated with cefpodoxime) were:
Diarrhea 6%
The incidence of diarrhea in infants and toddlers (age 1 month to 2 years) was 12.8%.
Diaper rash/Fungal skin rash 2% (includes moniliasis)
The incidence of diaper rash in infants and toddlers was 8.5%.
Other skin rashes 1.8%
Vomiting 2.3%
In clinical trials using
Adverse events thought possibly or probably related to cefpodoxime in single-dose clinical trials conducted in the United States were:
Nausea 1.4%
Diarrhea 1.2%
Dermatologic
Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of cefpodoxime proxetil, without regard to drug relationship, were:
Most of these abnormalities were transient and not clinically significant.
The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury,
One death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.
In addition to the adverse reactions listed above which have been observed in patients treated with cefpodoxime proxetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See
DOSAGE AND ADMINISTRATIONCefpodoxime proxetil tablets should be administered orally with food to enhance absorption. (See
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Acute bacterial exacerbations of chronic bronchitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Pharyngitis and/or tonsillitis | 200 mg | 100 mg Q 12 hours | 5 to 10 days |
| Acute community-acquired pneumonia | 400 mg | 200 mg Q 12 hours | 14 days |
| Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) | 200 mg | single dose | |
| Skin and skin structure | 800 mg | 400 mg Q 12 hours | 7 to 14 days |
| Acute maxillary sinusitis | 400 mg | 200 mg Q 12 hours | 10 days |
| Uncomplicated urinary tract infection | 200 mg | 100 mg Q 12 hours | 7 days |
| Type of Infection | Total Daily Dose | Dose Frequency | Duration |
|---|---|---|---|
| Acute otitis media | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 h (Max 200 mg/dose) | 5 days |
| Pharyngitis and/or tonsillitis | 10 mg/kg/day (Max 200 mg/day) | 5 mg/kg/dose Q 12 h (Max 100 mg/dose) | 5 to 10 days |
| Acute maxillary sinusitis | 10 mg/kg/day (Max 400 mg/day) | 5 mg/kg Q 12 hours (Max 200 mg/dose) | 10 days |
For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.
When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.
Males:
(mL/min) 72 x serum creatinine (mg/100 mL)
Females: 0.85 x above value
(mL/min)
OVERDOSAGEIn acute rodent toxicity studies, a single 5 g/kg oral dose produced no adverse effects.
In the event of serious toxic reaction from overdosage, hemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body, particularly if renal function is compromised.
The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea.
Probenecid:
Nephrotoxic drugs:
Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino}acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene- 2-carboxylate.
Its molecular formula is C21 H27 N5 O9 S2 and its structural formula is represented below:
The molecular weight of cefpodoxime proxetil is 557.6.
Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets.
Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil USP equivalent to 100 mg or 200 mg of cefpodoxime activity and the following inactive ingredients: carboxy methyl cellulose calcium, lactose monohydrate, hydroxy propyl cellulose, sodium lauryl sulfate, crospovidone, corn starch, magnesium stearate, hypromellose, titanium dioxide, propylene glycol and FD&C yellow #6 aluminum lake. In addition, the 100 mg film-coated tablets contain iron oxide yellow and the 200 mg film-coated tablets contain FD&C red #40 aluminum lake.